Single Center Open Prospective Study for the Comparison of Procedural Sequence in Same Day Consecutive Bidirectional Endoscopy
1 other identifier
observational
170
1 country
1
Brief Summary
The investigators study aim is to determine whether there is a any advantage in starting with upper or lower endoscopy. The main study objective will be the amount of analgesia needed for sustaining the examinee's comfort during the exams. Secondary endpoints will rate of detection of significant pathologies, total time of procedure, examinee's tolerance, time to recovery and examinee's satisfaction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2012
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2011
CompletedFirst Posted
Study publicly available on registry
December 13, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedFebruary 25, 2014
February 1, 2014
2.9 years
December 11, 2011
February 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dose of mephridine and midazolam
Dose of analgestices used in order to achive concious sedation
1 year
Secondary Outcomes (2)
Time to recovery
1 year
Rate of significant findings
1 year
Study Arms (1)
examinees undergoing bidirectional endoscopy
Study population will include sequential examinees undergoing bidirectional endoscopy, age\> 18 years
Eligibility Criteria
Study population will include sequential examinees undergoing bidirectional endoscopy. The decision to perform same day sequential bidirectional endoscopy is of the examinee's caring gastroenterologist, and not part of the study. Only examinees \> 18 years will be eligible.
You may qualify if:
- Age\> 18
- Same day bidirectional endoscopy
You may not qualify if:
- Prior failed endoscopy.
- Any major complication during previous endoscopy.
- Difficulty in communication with the patients.
- Psychiatric disease or mental retardation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sheba medical center
Ramat Gan, 55261, Israel
Related Publications (3)
Cho JH, Kim JH, Lee YC, Song SY, Lee SK. Comparison of procedural sequences in same-day bidirectional endoscopy without benzodiazepine and propofol sedation: starting at the bottom or the top. J Gastroenterol Hepatol. 2010 May;25(5):899-904. doi: 10.1111/j.1440-1746.2009.06157.x.
PMID: 20546443BACKGROUNDUrquhart J, Eisen G, Faigel DO, Mattek N, Holub J, Lieberman DA. A closer look at same-day bidirectional endoscopy. Gastrointest Endosc. 2009 Feb;69(2):271-7. doi: 10.1016/j.gie.2008.04.063. Epub 2008 Aug 23.
PMID: 18725159BACKGROUNDHardwick RH, Armstrong CP. Synchronous upper and lower gastrointestinal endoscopy is an effective method of investigating iron-deficiency anaemia. Br J Surg. 1997 Dec;84(12):1725-8.
PMID: 9448626BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Dan Carter, MD
Sheba Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Gasteroenterologist
Study Record Dates
First Submitted
December 11, 2011
First Posted
December 13, 2011
Study Start
January 1, 2012
Primary Completion
December 1, 2014
Study Completion
March 1, 2015
Last Updated
February 25, 2014
Record last verified: 2014-02